CGMP Compliance Products

CGMP Compliant Cleanroom Consumables For Pharmaceutical Manufacturing & 503b Outsourcing

CGMP or Current Good Manufacturing Practices provide for systems that ensure a proper set of processes are followed to ensure the safe manufacturing, quality and efficacy of pharmaceuticals. cGMPs help prevent errors and ensure no contamination during the drug manufacturing processes, all the way from the raw materials to finished drugs. The terms GMP and cGMP are often used synonymous, since when standards are updated, new regulations are quickly put into place. cGMP regulations always refer to the newest technologies available at the time of production. Pharmaceutical manufacturers in the United States must comply with cGMPs, which are regulated by the FDA.

cGMP Pharmaceutical Requirements & Enforcement

Each cGMP regulation has its own specific requirements that must be followed for manufacturing. However, many of the regulations apply to all pharmaceutical and medical device manufacturers. The FDA is responsible for enforcing cGMP regulations, therefore it’s imperative to make sure you are following the proper standard operating procedure (SOP) and using the correct sterile cleanroom apparel and pharmaceutical-grade cleanroom-grade sterile cleaning chemicals. Don’t be caught off-guard by a surprise FDA inspection or audit. During these inspections, the FDA checks out your facility and processes to ensure compliance. If the FDA finds evidence of non-compliance, it can take enforcement action against the company that can be costly, disruptive and potentially devastating. To ensure compliance with cGMP regulations, many pharmaceutical companies work with consultants or have on-staff experts that train staff and implement the correct rules and guidelines in their manufacturing processes. Here are the FDA regulations that apply to cGMPs for pharmaceutical manufacturing companies:

• 21 CFR Part 314 – For FDA approval to market a new drug
• 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals.
• 21 CFR Part 212 – Current Good Manufacturing Practice for Positron Emission Tomography Drugs.
• 21 CFR Part 600 – Biological Products: General

cGMP Cleanroom Consumables, Apparel & Cleaning

cGMP consumables include an array of sterile cleanroom apparel and sterile cleanroom cleaning supplies. Our pharmaceutical manufacturing clients that adhere to cGMP rely on us to stock their sterile apparel, clean room cleaning chemicals and related products. We supply cGMP-compliant patient-specific 503A pharmacies and 503B outsourcing facilities with all of the required sterile cleaning supplies, sterile apparel and other specialized sterility assurance products needed for compliance.

At other cleanroom suppliers, sterile cleanroom consumables are often backordered resulting in long delivery times that challenge your cleanroom staff’s ease of operating in your critical environment. We stock a full selection of sterile coveralls, sterile face masks, sterile hoods, sterile cleanroom gloves, sterile cleanroom wipes, sterile disinfectants & sporicidals, sterile goggles, sterile cleanroom mops, cleanroom paper, germ-killing sticky floor mats and other required consumable products for cGMP compliance. Our pharmacy outsourcing facility customers rely on us for weekly deliveries of all their sterile cleanroom pharmacy products. Our cGMP industry experts are available to specifically discuss your facility and the correct cleaning and maintenance SOP (Standard Operating Procedure).